Waters Corporation (NYSE: WAT) today announced that the Waters® ACQUITY UPLC® I-Class IVD/Xevo® TQ-S micro IVD System is now manufactured as a U.S. FD ...

Waters' newest MassTrak IVD LC-MS/MS System featuring the Xevo TQ Absolute IVD tandem quadrupole mass spectrometer (in dark grey), is up to five times more sensitive than similar commercial mass ...

"CE IVD marking of the QX200 ddPCR System is Bio-Rad's first step in extending ddPCR technology to the clinic," said Annette Tumolo, Executive Vice President for Bio-Rad's Digital Biology Group. "As a ...

CARLSBAD, Calif., Nov. 9, 2021 /PRNewswire/ -- As assay developers and clinical testing laboratories consider next steps for molecular diagnostics post-pandemic, a new in vitro diagnostic (IVD ...

While a risk-based framework for LDTs is novel, FDA has used such a system for IVDs for years. Class I IVDs are those which don’t support or sustain human life and have a safe and effective profile.

MBT Sepsityper Kit US IVD enables rapid, specific detection of many cases of bacteremia-induced sepsis to assist infectious disease specialists in potentially life-saving decisions Used for MALDI ...

The system has also met the CE mark requirements for IVD use in Europe and is registered with regulatory bodies for IVD use in many other countries. “We are pleased our CFX96 Dx Real-Time PCR System ...

Bruker continuously invests in bringing the MALDI Biotyper into clinical routine laboratories. In 2009, the IVD MALDI Biotyper received the CE-mark according to the European IVD directive EC/98/79.

The new CE-IVD marked MassARRAY System with Chip Prep Module joins the company's growing line of in vitro diagnostic devices for certain European countries, including the MassARRAY Dx Analyzer 4 ...

LONDON – Ibex Medical Analytics is preparing for commercial rollout in Europe after receiving CE-IVD marking for its artificial intelligence (AI) decision support system for automated interpretation ...

The system has also met the CE mark requirements for IVD use in Europe and is registered with regulatory bodies for IVD use in many other countries. "We are pleased our CFX96 Dx Real-Time PCR System ...